Browse hierarchy: [Dental (DE)](/submissions/DE) → [Subpart D — Prosthetic Devices](/submissions/DE/subpart-d%E2%80%94prosthetic-devices) → [21 CFR 872.3690](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3690) → OFW — Restorative Instrument And Component Tray

# OFW · Restorative Instrument And Component Tray

_Dental · 21 CFR 872.3690 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OFW

## Overview

- **Product Code:** OFW
- **Device Name:** Restorative Instrument And Component Tray
- **Regulation:** [21 CFR 872.3690](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/872.3690)
- **Device Class:** 2
- **Review Panel:** [Dental](/submissions/DE)

## Identification

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

## Classification Rationale

Class II.

## Recent Cleared Devices (0 of 0)

_No cleared devices on record._

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**Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OFW](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/OFW)

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